Cleared Traditional

K253649 - Spectral CT Verida Family (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence.

K253649 · Philips Medical Systems Technologies , Ltd. · Radiology device
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Mar 2026
Decision
127d
Days
Class 2
Risk

K253649 is an FDA 510(k) clearance for the Spectral CT Verida Family. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Philips Medical Systems Technologies , Ltd. (Haifa, IL). The FDA issued a Cleared decision on March 27, 2026 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Philips Medical Systems Technologies , Ltd. devices

Submission Details

510(k) Number K253649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2025
Decision Date March 27, 2026
Days to Decision 127 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 107d · This submission: 127d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Radiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT07108205 Completed Observational Industry-sponsored

Image Quality Study of Spectral Precise Image CT 7700

Clinical Study for Spectral Precise Image (SPI) Algorithm

126
Patients (actual)
3
Sites
Condition studied Head; Body; Cardiac
Eligibility All sexes · 22 Years+
Sponsor Philips Clinical & Medical Affairs Global (industry)
Started 2025-07-16 → Primary completion 2025-10-14
Primary outcome
Image Quality (IQ) of Spectral Precise Image reconstructions non inferior to iDose conventional images
Secondary outcome
Evaluation of the differences in Image Quality (IQ) of Spectral Precise Image reconstructions versus iDose conventional images
Study completed - no results published. This trial concluded in 2025 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

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All 816
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